JP4481633B2 - CATHETER AND METHOD FOR PRODUCING CATHETER - Google Patents

CATHETER AND METHOD FOR PRODUCING CATHETER Download PDF

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JP4481633B2
JP4481633B2 JP2003424003A JP2003424003A JP4481633B2 JP 4481633 B2 JP4481633 B2 JP 4481633B2 JP 2003424003 A JP2003424003 A JP 2003424003A JP 2003424003 A JP2003424003 A JP 2003424003A JP 4481633 B2 JP4481633 B2 JP 4481633B2
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catheter
tip
catheter shaft
distal end
shaft
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JP2004209243A (en
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クイント ボド
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アボット ラボラトリーズ バスキュラー エンタープライゼズ リミテッド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility

Description

本発明は、カテーテルおよびカテーテルの製造方法に関する。   The present invention relates to a catheter and a method for manufacturing the catheter.

身体の脈管または身体の穴の狭窄を拡げるために、膨張可能なバルーンを遠位端に含むカテーテル装置が現在用いられている。また、このような膨張可能なバルーン上でステントをクリンプ（収縮）し、ステントを狭窄部に配置して脈管壁を安定させることもできる。カテーテル装置は、患者の身体の狭窄（収縮）位置にガイドワイヤを用いて導かれる。バルーンを膨張することにより狭窄部が拡げられ、あるいは、クリンプされたステントが狭窄部に配置される。   Catheter devices that include an inflatable balloon at the distal end are currently used to expand the narrowing of body vessels or body holes. It is also possible to crimp the stent on such an inflatable balloon and place the stent in the stenosis to stabilize the vessel wall. The catheter device is guided to a stenosis (contraction) position of the patient's body using a guide wire. The stenosis is expanded by inflating the balloon, or a crimped stent is placed in the stenosis.

本発明の目的は、請求項１の冒頭に記載されたカテーテルを提供することにあり、このカテーテルは、その遠位端部にて特に高い柔軟性を有し、なおかつ、良好なプッシャビリティ（押し易さ）を得るための十分な安定性も有する。   The object of the present invention is to provide a catheter as described at the beginning of claim 1, which has a particularly high flexibility at its distal end and yet has good pushability (pushing). It also has sufficient stability to achieve ease.

本発明の目的は、請求項１に記載の特徴により達成される。   The object of the invention is achieved by the features of claim 1.

米国特許４，７８２，８３４号により、柔軟な先端を有するカテーテルが知られるが、このカテーテルの柔軟な先端は、より低安定性の材料への物質的な遷移により得られている。これは、先端全体が柔軟な材料からつくられ、したがってこの部分が曲がり易いという問題が生じることを意味する。この結果、先端が変形し、管腔の圧縮または永久変形を生じる可能性がある。   U.S. Pat. No. 4,782,834 discloses a catheter with a flexible tip, which is obtained by a material transition to a less stable material. This means that the entire tip is made of a flexible material, thus causing the problem that this part is easily bent. As a result, the tip may deform and cause compression or permanent deformation of the lumen.

バルーンカテーテルの質は、蛇行する脈管にカテーテルが容易に追従できること、および、カテーテルが狭窄部に、ガイドワイヤによりガイドされて可能な限り奥まで押し入れられること（「トラッキング」）による。このトラッキングは、先端がバルーンをガイドするように十分に柔軟であることにより補助される。特に遠位端（すなわち先端）が、特に好適な柔軟な材料からつくられている場合、システム全体が脈管の蛇行に追従できる。しかし同時に、カテーテルを脈管の狭窄部分に確実に押し込めることが保証されなければならない。この特性は「プッシャビリティ」と称される。米国特許４，７８２，８３４号に開示されているように、カテーテル先端の全体が柔軟な材料から形成されている場合、特にこの必要な特性が不都合に働く。カテーテル先端を押すと、カテーテル先端が可逆的または不可逆的に変形することがあり、これによりガイドワイヤにおいてもつれが生じることもある（摩擦）。先端の外形寸法を小さくし、すなわち、いわゆる病変部侵入プロフィールをより小さくすると、先端の機械的敏感さが増大し、かつ、先端のより多くの特性が、柔軟な材料により不都合に影響を受ける。   The quality of the balloon catheter is due to the fact that the catheter can easily follow the meandering vessel and that the catheter is pushed into the stenosis as far as possible, guided by a guide wire ("tracking"). This tracking is aided by the fact that the tip is sufficiently flexible to guide the balloon. The entire system can follow the meander of the vessel, especially if the distal end (ie, tip) is made from a particularly suitable flexible material. At the same time, however, it must be ensured that the catheter can be pushed into the stenosis of the vessel. This property is called “pushability”. This required property is particularly disadvantageous when the entire catheter tip is formed from a flexible material, as disclosed in US Pat. No. 4,782,834. Pushing the catheter tip can cause the catheter tip to reversibly or irreversibly deform, which can cause tangling in the guidewire (friction). Smaller tip dimensions, i.e., smaller so-called lesion penetration profiles, increase the mechanical sensitivity of the tip, and more properties of the tip are adversely affected by the flexible material.

しかし、細い狭窄部に通すためにカテーテルの侵入プロフィールが可能な限り小さいことが望ましいため、最小の侵入プロフィールを有しつつ機械的安定性があり、直径が連続的に増大することを特徴としながら柔軟であり、かつ、バルーン錐体への均一な遷移部を有する先端を形成できることが望ましい。本発明は、カテーテル先端がこれらの機械的特性を有するカテーテルおよびカテーテルの製造方法を開示する。   However, since it is desirable that the catheter's invasion profile be as small as possible to pass through a narrow stenosis, it is mechanically stable while having a minimal invasion profile and is characterized by a continuously increasing diameter. It is desirable to be able to form a tip that is flexible and has a uniform transition to the balloon cone. The present invention discloses a catheter having a catheter tip having these mechanical properties and a method for manufacturing the catheter.

（発明の開示）
本発明に従えば、カテーテルであって、カテーテル先端が、カテーテルシャフトの材料よりも柔軟な材料からつくられたジョイントを含むカテーテルが提供される。前記ジョイントは、バルーンカテーテルにおいて、バルーンの遠位端とカテーテル先端の遠位端の間に配置される。有利な実施形態において、カテーテル先端の遠位端はカテーテルシャフトと同一の材料からつくられる。さらなる有利な実施形態において、カテーテル先端の遠位端は、カテーテルシャフトの材料よりも硬質の材料からつくられる。カテーテル先端は、例えば金属の先端、金属リングであっても、またはＰＴＦＥ（ポリテトラフルオロエチレン）からつくられてもよい。先端は、コーティング、亜鉛めっきを施されることができ、すなわち、Ｘ線可視性または放射線不透過性である。 (Disclosure of the Invention)
In accordance with the present invention, a catheter is provided wherein the catheter tip includes a joint made from a material that is more flexible than the material of the catheter shaft. The joint is disposed in a balloon catheter between the distal end of the balloon and the distal end of the catheter tip. In an advantageous embodiment, the distal end of the catheter tip is made of the same material as the catheter shaft. In a further advantageous embodiment, the distal end of the catheter tip is made of a material that is harder than the material of the catheter shaft. The catheter tip may be, for example, a metal tip, a metal ring, or made from PTFE (polytetrafluoroethylene). The tip can be coated, galvanized, i.e. X-ray visible or radiopaque.

上記装置は、柔軟な先端と高いプッシャビリティとのほぼ最適な組合せを保証する。   The device assures an almost optimal combination of flexible tip and high pushability.

従属クレームは、本発明の有利な展開を含む。   The dependent claims contain advantageous developments of the invention.

請求項９には、以上に説明した本発明のカテーテルを製造する方法が開示されている。この方法の実施形態に従えば、或る材料、例えば、金属リングの形態の材料が、最初にバルーンの遠位端とカテーテルシャフトの前端の間の部分に付与される。この材料はカテーテルシャフトの材料より柔軟である。予備固定のために、この材料リングは、収縮チューブによりカテーテルシャフトに固定されることができる。次いで、溶接を、適切な放射エネルギーによる加熱により行う。放射エネルギーは、例えば、単色光もしくは多色光、レーザ光、電磁放射線、ホットエアまたは熱によりもたらされる。これにより、材料の溶融または材料の凝集を生じて、より柔軟な材料がカテーテルシャフトの所望の位置に一体化される。溶接は、好ましくは、速くかつ積極的なエネルギー作用により回転対称的に実行される。この一体化後、収縮チューブは除去され、全方向に移動可能なジョイントがカテーテルシャフトの遠位端部の所望の位置に固定される。   Claim 9 discloses a method for producing the catheter of the present invention described above. According to this method embodiment, a material, for example in the form of a metal ring, is first applied to the portion between the distal end of the balloon and the front end of the catheter shaft. This material is more flexible than the catheter shaft material. For pre-fixation, this material ring can be fixed to the catheter shaft by a shrink tube. The welding is then performed by heating with appropriate radiant energy. Radiant energy is provided, for example, by monochromatic or polychromatic light, laser light, electromagnetic radiation, hot air or heat. This causes the material to melt or agglomerate to integrate the softer material into the desired location on the catheter shaft. The welding is preferably carried out rotationally symmetrically with fast and positive energy action. After this integration, the shrink tube is removed and a omnidirectional joint is secured in the desired position at the distal end of the catheter shaft.

本発明のさらなる詳細、特徴および利点は、以下の実施形態の説明を、図面を参照しつつ読むことにより理解されよう。   Further details, features and advantages of the present invention will be understood by reading the following description of embodiments with reference to the drawings.

図１において、本発明のカテーテル１は、慣用的に形成されたカテーテルシャフト２を含み、カテーテルシャフト２の遠位端３に、近位端６および遠位端８を有するバルーン４が配置されている。   In FIG. 1, a catheter 1 of the present invention includes a conventionally formed catheter shaft 2 with a balloon 4 having a proximal end 6 and a distal end 8 disposed at the distal end 3 of the catheter shaft 2. Yes.

カテーテルシャフト２は、カテーテルシャフト２の一部であり、かつバルーン３の遠位端８を越えて突出するカテーテル先端７を有する。   The catheter shaft 2 has a catheter tip 7 that is part of the catheter shaft 2 and projects beyond the distal end 8 of the balloon 3.

本発明のカテーテル１のカテーテル先端７は、カテーテルシャフト２の材料よりも柔軟な材料から構成されたジョイント９を含む。前記ジョイント９は、バルーン４の遠位端８とカテーテル先端７の前端１０またはカテーテルシャフト２の前端１０との間に配置されている。したがって、一方ではカテーテル先端７の柔軟な特性が達成され、他方では高いプッシャビリティが保証される。なぜなら、カテーテル先端７の前端１０は、カテーテルシャフト２と同一の硬質の材料、または、より硬質の材料からつくられるからである。   The catheter tip 7 of the catheter 1 of the present invention includes a joint 9 made of a material that is more flexible than the material of the catheter shaft 2. The joint 9 is arranged between the distal end 8 of the balloon 4 and the front end 10 of the catheter tip 7 or the front end 10 of the catheter shaft 2. Thus, on the one hand, the flexible properties of the catheter tip 7 are achieved and on the other hand a high pushability is ensured. This is because the front end 10 of the catheter tip 7 is made of the same hard material as the catheter shaft 2 or a harder material.

図２に、本発明の方法を説明するためにカテーテル１の遠位端部が示されている。この方法において、最初に或る材料を、バルーンの遠位端８とカテーテルシャフト２の前端１０の間の部分に供与する（付ける）。この材料はカテーテルシャフト２の材料よりも柔軟である。この材料は、例えば、望ましい位置に、リング１１の形態で供与され得る。図２に示した特に有利な実施形態において、前記リング１１の予備固定が、収縮箔１２を用いて行われる。次いで、図２に２本の波矢印Ｌで示されている放射線エネルギーを材料１１に加え、これにより、前記材料１１が、図１に示したカテーテルシャフトの材料と一体化され、こうして柔軟なジョイント９が形成される。   In FIG. 2, the distal end of the catheter 1 is shown to illustrate the method of the present invention. In this method, a material is first dispensed onto the portion between the distal end 8 of the balloon and the front end 10 of the catheter shaft 2. This material is more flexible than the material of the catheter shaft 2. This material can be dispensed in the form of a ring 11, for example, at a desired location. In a particularly advantageous embodiment shown in FIG. 2, the ring 11 is preliminarily fixed using a shrink foil 12. Then, the radiation energy indicated by the two wave arrows L in FIG. 2 is applied to the material 11 so that the material 11 is integrated with the material of the catheter shaft shown in FIG. 9 is formed.

図３に、本発明のカテーテル１の第２の実施形態が開示されており、このカテーテルもまた、遠位前端１０を有するカテーテル先端７を有するカテーテルシャフト２を含む。   FIG. 3 discloses a second embodiment of the catheter 1 of the present invention, which also includes a catheter shaft 2 having a catheter tip 7 having a distal front end 10.

しかし、図３に示されているカテーテルはバルーンを含まない。したがって、図１および図２のジョイント９に原則として対応するジョイント９は、カテーテル先端７の付近に配置される。   However, the catheter shown in FIG. 3 does not include a balloon. Accordingly, the joint 9 corresponding in principle to the joint 9 of FIGS. 1 and 2 is arranged in the vicinity of the catheter tip 7.

カテーテル先端７もまた、カテーテルシャフト２と同一の材料、または、より硬質の材料からつくられることができる。   The catheter tip 7 can also be made of the same material as the catheter shaft 2 or a harder material.

さらなる別の実施形態において、超音波ヘッド（図には示さず）をカテーテルシャフト２の遠位端に設けることができる。このような実施形態において、ジョイント９は、前記超音波ヘッドとカテーテル先端７の遠位端１０の間に配置される。   In yet another embodiment, an ultrasonic head (not shown) can be provided at the distal end of the catheter shaft 2. In such an embodiment, the joint 9 is disposed between the ultrasound head and the distal end 10 of the catheter tip 7.

図１は、本発明のカテーテルの概略図である。FIG. 1 is a schematic view of the catheter of the present invention. 図２は、本発明の方法を説明するための、図１のカテーテルの遠位端部の、図１に対応した図である。FIG. 2 is a view corresponding to FIG. 1 of the distal end of the catheter of FIG. 1 for explaining the method of the present invention. 図３は、本発明のカテーテルの第２の実施形態の、図１に対応した図である。FIG. 3 is a view corresponding to FIG. 1 of the second embodiment of the catheter of the present invention.

Claims (4)

カテーテルシャフト（２）、および、カテーテルシャフト（２）の一部であるカテーテル先端（７）を含むカテーテル（１）の製造方法であって、
カテーテルシャフト（２）の材料よりも柔軟な材料（１１）をカテーテル先端（７）に供与するステップと、
該供与された材料（１１）を放射線エネルギーで処理するステップと、
該供与された材料（１１）をカテーテルシャフトの材料に材料の凝集により溶接して該供与された材料（１１）をカテーテルシャフトの材料と一体化してジョイント（９）を形成するステップを含む方法。 A method of manufacturing a catheter (1) comprising a catheter shaft (2) and a catheter tip (7) that is part of the catheter shaft (2) ,
Providing the catheter tip (7) with a material (11) that is softer than the material of the catheter shaft (2) ;
Treating the donated material (11) with radiation energy;
Method comprising the steps of forming a joint (9) the donor material (11) is welded by aggregation of the material in the material of the catheter shaft said donor material (11) integral with the material of the catheter shaft. 該供与された材料（１１）が溶接ステップ前に予備固定されることを特徴とする請求項１に記載の方法。 The method according to claim 1, characterized in that said donor material (11) is pre-fixed prior to welding step. 予備固定のために収縮チューブが用いられることを特徴とする請求項1又は２に記載の方法。 3. A method according to claim 1 or 2 , characterized in that a shrink tube is used for pre-fixation. カテーテルシャフト（２）と、A catheter shaft (2);
カテーテル先端（７）と、A catheter tip (7);
該カテーテルシャフト（２）とカテーテル先端（７）との間のジョイント（９）を含むカテーテル（１）において、In a catheter (1) comprising a joint (9) between the catheter shaft (2) and the catheter tip (7),
該ジョイント（９）が、該カテーテルシャフトより柔軟な材料を、該材料の凝集により該カテーテルシャフト（２）と一体化されることにより形成されていることを特徴とするカテーテル（１）。The catheter (1), wherein the joint (9) is formed by integrating a material softer than the catheter shaft with the catheter shaft (2) by aggregation of the material.
JP2003424003A 2002-12-31 2003-12-22 CATHETER AND METHOD FOR PRODUCING CATHETER Expired - Lifetime JP4481633B2 (en)

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US8323432B2 (en) 2012-12-04
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US7972324B2 (en) 2011-07-05
DE50209306D1 (en) 2007-03-08
CA2454468C (en) 2011-08-30
US20040210210A1 (en) 2004-10-21
US20110257526A1 (en) 2011-10-20
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CA2454468A1 (en) 2004-06-30

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